What is Amphora?

Amphora (clinically known as Acidform) is a lubricating vaginal gel that has demonstrated efficacy in preventing conception and STIs in extensive in-vitro studies and human clinical trials.

How does Amphora work?

Amphora has been specially designed to lend extended protection to the vagina and cervix and to enhance a woman’s natural vaginal defenses. When inserted vaginally, Amphora forms a bioadhesive, protective barrier to sperm and STI-causing microbes over the vaginal/cervical surface. This bioadhesive nature enables protection hours after insertion. When in place, Amphora also maintains the vaginal pH at its natural acidic level that is hostile to sperm and STI-causing microbes. This is done through a pH-buffering mechanism. Finally, for additional added cervical protection, Amphora will be dosed with a disposable diaphragm.

...as a contraceptive
Amphora, through its bioadhesive nature, entraps sperm and inhibits sperm migration into cervical mucus. When present in the vagina, Amphora maintains the natural pH level of a woman's vagina (generally accepted to be pH 5.0 or less) even when semen, an alkaline substance, is introduced. Studies have shown that AMPHORA will maintain a pH of 5.0 or less even in the presence of a 3.4 fold excess of semen and that even a 1:8 dilution of ACIDFORM still retains a pH of 4.6-4.8 after mixing with semen.  The motility of all spermatozoa is inhibited even if semen is present in 3-4 fold excess. AMPHORA effectively prevents sperm migration into cervical mucus in vitro. In a comparative study, AMPHORA was found to be as effective as a marketed nononxynol-9 formulation.

...as a microbicide

Amphora’s bioadhesive nature and acid-buffering qualities in tandem deliver protection from the transmission of sexually-transmitted infections. Similar to the contraceptive action, the gel entraps and inhibits microbe migration into the vaginal and cervical mucus and tissue. The acidic vaginal state maintained by the presence of Amphora is hostile to numerous STI-causing microbes. Amphora and/or acidic environments have shown in vitro and in animal studies to be effective against HIV and other sexually transmitted infection-causing organisms including herpes, chlamydia, gonococci (gonorrhea), and bacterial vaginosis.

BufferGel™

BufferGel is another microbicide candidate in development by ReProtect Inc. (www.reprotect.com). Amphora and BufferGel are the only two microbicide candidates with the “acid-buffering” mechanism of action described above. Instead owns exclusive rights to commercialize BufferGel, however, we are focusing all our efforts on the development of Amphora as it is a “second-generation” microbicide and shows greater promise in being an effective contraceptive and STI-preventing lubricant. Amphora is several times more viscous that BufferGel, and twice as much BufferGel is needed to reach the same effectiveness as Amphora. Amphora is more bio-adhesive, causing it to stay in place in the vagina and not leak out. For more information on BufferGel, visit the ReProtect website (www.reprotect.com).

Amphora highlights

• Amphora inhibits sperm motility, i.e., is spermicidal, even in the presence of three times the volume of semen.

• Amphora is as spermicidal in women as nonoxynol-9

• Amphora prevents sperm penetration into cervical mucus of women as effectively as nonoxynol-9.

• Amphora remains in the vagina for at least 8-10 hours, retaining almost full spermicidal activity.

• Amphora is safe when applied for 6 consecutive days to the vagina of women.

• Amphora is safe when used during intercourse.

• Amphora does not inactivate lactobacilli, an important protective vaginal microbe, either in the laboratory or in women.

• Amphora is an effective acid-buffering formulation; it is much more acid-buffering than Aci-Jel, the only vaginal hygiene product claimed to possess acid-buffering properties.

• Amphora is more biadhesive in laboratory studies than any of the other vaginal formulations tested, including KY jelly, Aci-Jel, Replens, Advantage S and Conceptrol.

• Amphora retains its viscosity on dilution better in laboratory studies than KY jelly, Aci-Jel, Replens, Advantage S and Conceptrol.

• Amphora is stable for at least 2 years at room temperature.

• Amphora decreases the chance of vaginal transmission of herpes virus, chlamydia and gonorrhea in an animal model.

• Amphora inhibits BV-and vaginitis-causing microbes, and trichomonas, in laboratory studies.

Patented - Instead holds worldwide exclusive rights.

Strategic partners to commercialize the lubricant and complete final 6-month contraceptive clinical. Private equity investment with liquidity event in 18-24 months.